Practical Considerations for Adaptive Trial Design and Implementation

Chapter 1 The Need for and the Future of Adaptive Designs in Clinical Development

Chapter 2 Regulatory Guidance Documents on Adaptive Designs: An Industry Perspective

Chapter 3 A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences

Chapter 4 Considerations and Optimization of Adaptive Trial Design in Clinical Development Programs

Chapter 5 Optimal Cost-Effective Go–No Go Decisions in Clinical Development

Chapter 6 Timing and Frequency of Interim Analyses in Confirmatory Trials

Chapter 7 Approaches for Optimal Dose Selection for Adaptive Design Trials

Chapter 8 A Review of Available Software and Capabilities for Adaptive Designs

Chapter 9 Randomization Challenges in Adaptive Design Studies

Chapter 10 Response-Adaptive Randomization for Clinical Trials

Chapter 11 Implementing Adaptive Designs: Operational Considerations, Putting It All Together

Chapter 12 Implementation Issues in Adaptive Design Trials

Chapter 13 Implementing Adaptive Designs: Using Technology to Protect Trial Integrity, Reduce Operational Bias, and Build Regulatory Trust

Chapter 14 Considerations for Interim Analyses in Adaptive Trials, and Perspectives on the Use of DMCs

Chapter 15 Approaches for Clinical Supply Modelling and Simulation

Chapter 16 Approaches for Patient Recruitment Modeling and Simulation

Chapter 17 A Case Study for Adaptive Trial Design Consideration and Implementation

Chapter 18 Case Study: Design Considerations for a Phase Ib Randomized, Placebo-Controlled, 4-Period Crossover Adaptive Dose-Finding Clinical Trial

Chapter 19 Continual Reassessment Method for a First-in-Human Trial: From Design to Trial Implementation

Chapter 20 Practical Considerations for a Two-Stage Confirmatory Adaptive Clinical Trial Design and Its Implementation: ADVENT Trial